Almost all of us have heard of the FDA, or Food and Drug Administration. Translated into English, it is nothing more than the Food and Drug Administration. But what exactly is the FDA and where does it come from?
It is an institution with its origins in the United States. Its main social charge lies in regulating everything related to the health field of that nation, although some of its orders include the rest of the countries of the world.
👉 Why is it so important to know what is the FDA?
Thanks to this U.S. governmental structure, established in 1906 under the Federal Food and Drug Act, the following factors are met:
✅ It protects public health through regulatory mechanisms.
✅ It favors product innovations that support public health, as it has annual budgets in excess of billions of dollars.
✅ It provides the necessary information, scientifically demonstrated, for the preservation of citizens’ health. As well as the use of medicines and food intake.
The FDA is present through its offices in all 50 states. In addition, it extends to: District of Columbia, Puerto Rico, Guama, the Virgin Islands, American Samoa and other territories and possessions of the United States of America (USA). Since 2008, its staff is also located in China, India, Costa Rica, Chile, Belgium and the United Kingdom, among other nations.
The next time you hear what the FDA is, you will be able to answer in a safe way. Ground that answer with the argument that the agency monitors and oversees the safety of:
✅ Tobacco derivatives.
✅ Food and dietary supplements.
✅ Animal feed and veterinary products.
✅ Blood transfusions and other blood supplements.
✅ Biopharmaceuticals, prescription and over-the-counter drugs.
✅ Medical devices and equipment, electromagnetic radiation emitting devices (ERED) and other items related to human and animal health.
What are the requirements for exporting food at the FDA?
You already know what the FDA is. But before knowing about its requirements for importing or marketing in the United States of regulated products you must register with that institution.
👉 Who can become accredited with the institution?
By accessing its official website with service in English and Spanish on the Internet they will be able to enter for free:
✅ Manufacturers or processors
✅ Storage operators.
The frequency of registration has a biannual character. A new insertion must be made after: change of address, owner or when merging companies. To execute this operation online, it is necessary to fill in the following fields:
✅ Explain a unique facility identifier (UFI) recognized by the FDA. To be on the safe side, the code can be acquired from the Data Universal Numbering System (DUNS).
✅ Define elements of importance of the company such as: type of business (if distributor or broker), name of the facility and owner, mailing address, if it belongs to a parent company, trademarks, contact details….
✅ Specify the U.S. agency that will mediate the exchange in case of a foreign identity.
✅ Detail the characteristics of the storage.
Indicate, on a mandatory basis, the person who authorized the transfer of this record.
This procedure will allow you to obtain a PIN and a registration number. It is received immediately or after a few days by return e-mail. To export to the United States, this is the first and most important requirement. Not many people are interested in what the FDA is for nothing, because it is involved in all health regulatory mechanisms.
Another important obligation is: Prior Notification of Imported Food. It refers to exporters, who will send a pre-import notification to the FDA with:
Date of arrival of the imported food.
The ports of entry.
The contents of the food.
This notice will have the following deadlines:
✅ By land: no more than 5 days prior to shipment and no less than 2 hours prior to arrival.
✅ By air and rail: 4 hours prior to arrival.
✅ By sea: 8 hours prior to arrival.
✅ By post: Before the product is shipped.
In addition, such products will have to be accompanied by the electronic confirmation issued by the FDA.
Another requirement to keep in mind is safety. Through the Good Manufacturing Practices, regulations are established to maintain hygiene and proper handling of food during manufacturing and trade. In addition, quantities must comply with the laws issued by federal entities.
In case substances or components are intentionally added, they can only be those pre-established as:
✅ Additives: Colorants and safe substances, with prior certification.
✅ Contaminants: Pesticides and other products of an agricultural or pest controller nature; provided they do not exceed the tolerance or permissibility level.
✅ Labels: Possess relevant, truthful and accurate information related to food. The letters, identity, nutritional characteristics and date of processing activity are essential.
This organization has other significant requirements as well. However, we have talked about the most general ones. Thus, you will already be able to give an answer to what the FDA is in a global way.
What are the FDA regulations?
We have gone through a comprehensive topic: what is the FDA, what are its functions, requirements to market food, how to register, etc. At this point it is vital to point out that this agency is divided into six fundamental centers:
CBER (Center for Biological Evaluation and Research).
➡ CDRH (Center for Devices and Radiological Health).
➡ CDER (Center for Drug Evaluation and Research).
➡ CFSAN (Center for Food Safety and Applied Nutrition).
➡ CVM (Center for Veterinary Medicine).
➡ CTP (Center for Tobacco Products).
You may be questioning why we tell you that. If what you want to know is what the FDA and its regulations are, then you will understand better after identifying the above information.
Each of these areas of focus not only have different histories and origins; they also contain different regulations. Hence, we cannot tell you all of them. As you may have noticed, breaking down the question of what is the FDA requires touching on these and many other topics.
Regarding the regulations:
✅ Orphan Drug Act.
✅ Biologics Products Control Act.
✅ Public Health Services Act, or PHS Act.
✅ Administrative Procedures Act, or APA.
✅ Pediatric Research Equity Act, or PREA.
✅ National Childhood Vaccine Injury Act.
✅ Prescription Drug User Fee Act.
✅ Federal Food, Drug, and Cosmetic Act, or FD&C Act.
✅ Food and Drug Administration Modernization Act, or FDAMA.
✅ Medical Device User Fee and Modernization User Fee Act, or MDUFA.
✅ Public Health, Security, and Bioterrorism Preparedness and Response Act.
FDA certification what is it and how to get it out?
After knowing what the U.S. FDA is you already understand its power to review, evaluate and approve a wide range of health-related items. In its absence, marketers of drugs and related additives can talk about their performance without proven validity.
Currently, this is not the case, as companies must carry an FDA-accredited certificate. To obtain it, they have to demonstrate to the institution the safety and efficacy of their service. The following steps are required to achieve this:
Drug development: A company wants to sell a drug in the United States that it manufactures. It needs to apply for FDA approval.
Animal testing: Studies currently evaluate products in animals before knowing their validity in humans.
IND application (for investigational new drug): There is the possibility of requesting approval for investigational new drug based on previous results. This section includes the composition of the drug, its manufacture and the planning of the purpose for the evaluation of the product in humans.
Clinical trials: Once the previous procedure has been approved, human trials begin. In order to fulfill this facet, it is necessary to take into account each one of the established procedures. At the end, it is mandatory to submit a detailed study report to the FDA.
New Drug Application (NDA): The application is formalized. Then, they proceed to the review and the agency approves or not the drug or related product.
In general, these are the steps to award a drug to the sales network in the United States. However, when we talked to you about what the FDA is, we also said that it is a general mechanism. Its mission is not only to approve or not the efficacy of a product. It also regulates the way in which it will be marketed.
In that sense, sellers demand to follow the procedures issued by the government establishment; it is because the FDA also:
✅ Reviews the labeling of medical products.
✅ Inspects facilities and storages.
✅ Submits companies to cybersecurity searches frequently.
All health-related companies need to take out FDA certification. Even, those whose trades are released for sale (painkillers, home therapy devices, massage machines…) require it just the same.
Today you have learned about what the FDA is and how it works. You may find it complex, but the important thing is that you had a first approach. Now you know where to start preparing if you want to apply. Good luck!